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Federal Register / Vol. 71, No.

144 / Thursday, July 27, 2006 / Notices 42645


Number of Avg. burden/
Number of Total burden
Form responses per response
respondents (hours)
respondents (in hours)

Health and QOL questionnaire Final ............................................................... 3000 2 20/60 2000

Total .......................................................................................................... ........................ ........................ ........................ 2184

Dated: July 21, 2006. Dated: July 20, 2006. (HFZ–220), Center for Devices and
Joan F. Karr, Alvin Hall, Radiological Health, Food and Drug
Acting Reports Clearance Officer, Centers for Director, Management Analysis and Services Administration, 1350 Piccard Dr.,
Disease Control and Prevention. Office, Centers for Disease Control and Rockville, MD 20850. Send one self-
[FR Doc. E6–12025 Filed 7–26–06; 8:45 am] Prevention. addressed adhesive label to assist that
BILLING CODE 4163–18–P [FR Doc. E6–12015 Filed 7–26–06; 8:45 am] office in processing your request, or fax
BILLING CODE 4163–18–P your request to 240–276–3151. See the
DEPARTMENT OF HEALTH AND information on electronic access to the
HUMAN SERVICES Submit written comments concerning
Centers for Disease Control and this guidance to the Division of Dockets
Prevention Food and Drug Administration Management (HFA–305), Food and Drug
[Docket No. 2006D–0275] Administration, 5630 Fishers Lane, rm.
Disease, Disability, and Injury 1061, Rockville, MD 20852. Submit
Prevention and Control Special Guidance for Industry and Food and electronic comments to http://
Emphasis Panel (SEP): CDC Public Drug Administration Staff; Class II www.fda.gov/dockets/ecomments.
Health Research: Health Protection Special Controls Guidance Document: Identify comments with the docket
Research Initiative Graduate Training Fecal Calprotectin Immunological Test number found in brackets in the
Program Grant, Request for Systems; Availability heading of this document.
AGENCY: Food and Drug Administration, Deborah Moore, Center for Devices and
In accordance with section 10(a)(2) of HHS. Radiological Health (HFZ–440), Food
the Federal Advisory Committee Act ACTION: Notice. and Drug Administration, 2098 Gaither
(Pub. L. 92–463), the Centers for Disease Rd., Rockville, MD 20850, 240–276–
Control and Prevention (CDC) SUMMARY: The Food and Drug
announces the following meeting: Administration (FDA) is announcing the
availability of the guidance entitled SUPPLEMENTARY INFORMATION:
Name: Disease, Disability, and Injury
‘‘Class II Special Controls Guidance I. Background
Prevention and Control Special Emphasis
Panel (SEP): CDC Public Health Research:
Document: Fecal Calprotectin
Immunological Test Systems.’’ This Elsewhere in this issue of the Federal
Health Protection Research Initiative Register, FDA is publishing a final rule
Graduate Training Program Grant, Request guidance document describes a means
by which fecal calprotectin classifying fecal calprotectin
for Applications (RFA) CD07–001.
immunological test systems may comply immunological test systems into class II
Time and Date: 12 p.m.–4 p.m., September
14, 2006 (Closed). with the requirement of special controls (special controls) under section 513(f)(2)
Place: Teleconference. for class II devices. Elsewhere in this of the Federal Food, Drug, and Cosmetic
Status: The meeting will be closed to the issue of the Federal Register, FDA is Act (the act) (21 U.S.C. 360c(f)(2)). This
public in accordance with provisions set publishing a final rule to classify fecal notice announces the guidance
forth in Section 552b(c)(4) and (6), Title 5
calprotectin immunological test systems document that will serve as the special
U.S.C., and the Determination of the Director, control for fecal calprotectin
Management Analysis and Services Office,
into class II (special controls). This
guidance document is immediately in immunological test systems.
CDC, pursuant to Public Law 92–463. Section 513(f)(2) of the act provides
Matters To Be Discussed: The meeting will effect as the special control for fecal
that any person who submits a
include the review, discussion, and calprotectin immunological test
premarket notification under section
evaluation of applications received in systems, but it remains subject to
510(k) of the act (21 U.S.C. 360(k)) for
response to RFA CD07–001, ‘‘CDC Public comment in accordance with the
Health Research: Health Protection Research a device that has not previously been
agency’s good guidance practices
Initiative Graduate Training Program Grant.’’ classified may, within 30 days after
Contact Person For More Information: receiving an order classifying the device
Christine Morrison, PhD., Scientific Review DATES: Submit written or electronic in class III under section 513(f)(1) of the
Administrator, Office of Extramural comments on this guidance at any time. act, request FDA to classify the device
Research, CDC, 1600 Clifton Road, NE., General comments on agency guidance under the criteria set forth in section
Mailstop D72, Atlanta, GA 30333, Telephone documents are welcome at any time. 513(a)(1) of the act. FDA shall, within
404.639.3098. ADDRESSES: Submit written requests for 60 days of receiving such a request,
The Director, Management Analysis and single copies of the guidance document classify the device by written order.
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Services Office, has been delegated the

authority to sign Federal Register notices
entitled ‘‘Class II Special Controls This classification shall be the initial
pertaining to announcements of meetings and Guidance Document: Fecal Calprotectin, classification of the device. Within 30
other committee management activities, for Immunological Test Systems’’ to the days after the issuance of an order
both CDC and the Agency for Toxic Division of Small Manufacturers, classifying the device, FDA must
Substances and Disease Registry. International, and Consumer Assistance publish a notice in the Federal Register

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42646 Federal Register / Vol. 71, No. 144 / Thursday, July 27, 2006 / Notices

announcing such classification. Because IV. Paperwork Reduction Act of 1995 Open: September 18, 2006, 9 a.m. to 3 p.m.
of the timeframes established by section Agenda: Psychoactive Drugs and Type 2
This guidance refers to previously Diabetes.
513(f)(2) of the act, FDA has approved collections of information Place: National Institutes of Health, 9000
determined, under § 10.115(g)(2) (21 found in FDA regulations. These Rockville Pike, Building 45, Conference
CFR 10.115(g)(2)), that it is not feasible collections of information are subject to Rooms E1/E2.
to allow for public participation before review by the Office of Management and Contact Person: Sanford A. Garfield, PhD,
issuing this guidance as a final guidance Budget (OMB) under the Paperwork Senior Advisor, Biometrics and Behavioral
document. Thus, FDA is issuing this Reduction Act of 1995 (44 U.S.C. 3501– Science, National Institute of Diabetes and
guidance document as a level 1 3520). The collections of information in Digestive and Kidney Diseases, National
guidance document that is immediately Institutes of Health, PHS, DHHS, 6707
21 CFR part 807, subpart E, have been
Democracy Blvd, Room 685, Bethesda, MD
in effect. FDA will consider any approved under OMB control number 20892, 301–594–8803,
comments that are received in response 0910–0120, the collections of Garfields@extra.niddk.nih.gov.
to this notice to determine whether to information in 21 CFR part 820 have Information is also available on the
amend the guidance document. been approved under OMB control Institute’s/Center’s Web site: http://
number 0910–0073, and the collections www.niddk.nih.gov/federal/dmicc.htm,
II. Significance of Guidance where an agenda and any additional
of information in 21 CFR part 809 have
been approved under OMB control information for the meeting will be posted
This guidance is being issued when available. For logistics and updated
consistent with FDA’s good guidance number 0910–0485.
information not available on the Web site,
practices regulation (§ 10.115). The V. Comments contact Maria Smith, The Scientific
guidance represents the agency’s current Consulting Group, Inc., contractor for the
Interested persons may submit to the DMICC, at msmith@scgcorp.com.
thinking on fecal calprotectin
Division of Dockets Management (see Please note: In the interest of security, NIH
immunological test systems. It does not
ADDRESSES) written or electronic has instituted stringent procedures for
create or confer any rights for or on any comments regarding this document. entrance into the building by non-
person and does not operate to bind Submit a single copy of electronic government employees. Persons without a
FDA or the public. An alternative comments or two paper copies of any government I.D. will need to show a photo
approach may be used if such approach mailed comments, except that I.D. and sign in at the security desk upon
satisfies the requirements of the individuals may submit one copy. entering the building. Visitors may be
applicable statute and regulations. Comments are to be identified with the required to pass through a metal detector and
have bags, backpacks, or purses inspected or
III. Electronic Access docket number found in brackets in the
x-rayed as they enter NIH buildings. For
heading of this document. Received more information about the new security
Persons interested in obtaining a copy comments may be seen in the Division measures at NIH, please visit the Web site at
of the guidance may do so by using the of Dockets Management between 9 a.m. http://www.nih.gov/about/
Internet. To receive ‘‘Class II Special and 4 p.m., Monday through Friday. visitorsecurity.htm.
Controls Guidance Document: Fecal Dated: July 19, 2006. Dated: July 20, 2006.
Calprotectin Immunological Test Linda S. Kahan, Sanford A. Garfield,
Systems,’’ you may either send an e- Deputy Director, Center for Devices and Senior Advisor, National Institute of Diabetes
mail request to dsmica@fda.hhs.gov to Radiological Health. and Digestive and Kidney Diseases, National
receive an electronic copy of the [FR Doc. E6–11974 Filed 7–26–06; 8:45 am] Institutes of Health.
document or send a fax request to 240–
BILLING CODE 4160–01–S [FR Doc. E6–12046 Filed 7–26–06; 8:45 am]
276–3151 to receive a hard copy. Please
use the document number 1599 to
identify the guidance you are DEPARTMENT OF HEALTH AND
CDRH maintains an entry on the HUMAN SERVICES
Internet for easy access to information National Institutes of Health
including text, graphics, and files that Substance Abuse and Mental Health
National Institute of Diabetes and Services Administration
may be downloaded to a personal
Digestive and Kidney Diseases; Notice
computer with Internet access. Updated
of Meeting Agency Information Collection
on a regular basis, the CDRH home page
includes device safety alerts, Federal Pursuant to section 429 [285c–3] of Activities: Submission for OMB
Register reprints, information on the Public Health Service Act (Pub. L. Review; Comment Request
premarket submissions (including lists 95–158), notice is hereby given of a Periodically, the Substance Abuse and
of approved applications and meeting of the statutory Diabetes Mental Health Services Administration
manufacturers’ addresses), small Mellitus Interagency Coordinating (SAMHSA) will publish a summary of
manufacturer’s assistance, information Committee. information collection requests under
on video conferencing and electronic The meeting will be open to the OMB review, in compliance with the
submissions, Mammography Matters, public as indicated below, with Paperwork Reduction Act (44 U.S.C.
and other device-oriented information. attendance limited to space available. Chapter 35). To request a copy of these
The CDRH Web site may be accessed at Individuals who plan to attend and documents, call the SAMHSA Reports
http://www.fda.gov/cdrh. A search need special assistance, such as sign Clearance Officer on (240) 276–1243.
capability for all CDRH guidance language interpretation or other
documents is available at http:// reasonable accommodations, should Proposed Project: Screening, Brief
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www.fda.gov/cdrh/guidance.html. notify the Contact Person listed below Intervention, Brief Treatment and
Guidance documents are also available in advance of the meeting. Referral to Treatment (SBIRT) Cross-
on the Division of Dockets Management Site Evaluation—New
Name of Committee: Diabetes Mellitus
Internet site at http://www.fda.gov/ Interagency Coordinating Committee. SAMHSA’s Center for Substance
ohrms/dockets. Date: September 18, 2006. Abuse Treatment is conducting a cross-

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